VIRTUS PHARMACEUTICALS LLC. – FDA Inspection, Feb 1, 2018

Record Details

This FDA Inspection record concerns VIRTUS PHARMACEUTICALS LLC., with an inspection on February 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: VIRTUS PHARMACEUTICALS LLC.
Inspection Date: February 1, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Anastasia I. Onuorah (Company Rep)

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ID · aaac3217-eca4-476f-a47c-caf152d1a295

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1039294
FDA center: Human Drugs
Project area: Postmarket Surv. and Epidemiology
Outcome: Form 483 issued

FDA Citations

21 CFR 314.80(c)(2)Late submission of annual safety reports
21 CFR 314.80(c)(2)Late submission of quarterly safety reports
21 CFR 314.80(c)(2)Interval
21 CFR 314.80(b)Failure to develop written procedures

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FDA Inspection

VIRTUS PHARMACEUTICALS LLC.February 1, 2018